TRIFEME ethinylestradiol/levonorgestrel tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ethinylestradiol, Quantity: 0.03 mg; levonorgestrel, Quantity: 0.125 mg

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; magnesium stearate; maize starch; glycol montanate; sucrose; povidone; titanium dioxide; iron oxide yellow; calcium carbonate; glycerol; purified talc; macrogol 6000

Administration route:

Oral

Units in package:

4 x 28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Indicated for the prevention of pregnancy.

Product summary:

Visual Identification: 10 yellow round biconvex 6mm diameter tablets.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1992-06-05

Patient Information leaflet

TRIFEME
®
_Levonorgestrel and Ethinylestradiol Tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Trifeme. It does not
contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Trifeme
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY QUESTIONS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TRIFEME IS USED
FOR
Trifeme is an oral contraceptive,
commonly known as a "birth control
pill" or "the Pill". Trifeme tablets
contain two hormones
(levonorgestrel and ethinylestradiol),
which prevent you from becoming
pregnant if taken correctly. They are
similar to the hormones that your
body normally produces.
Trifeme prevents pregnancy in
several ways:
•
It inhibits the egg release by
stopping it maturing
•
It changes the cervical mucus
consistency making it difficult for
the sperm to reach the egg
•
It changes the lining of the uterus
making it less suitable for
implantation.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TRIFEME HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Trifeme for another reason.
This medicine is only available with
a doctor's prescription.
Trifeme is not habit-forming.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU TAKE
TRIFEME
_WHEN YOU MUST NOT TAKE_
_TRIFEME_
DO NOT TAKE TRIFEME IF YOU HAVE AN
ALLERGY TO:
•
ANY MEDICINE CONTAINING
ETHINYLESTRADIOL OR
LEVONORGESTREL
•
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET
•
ANY OTHER SIMILAR MEDICINES
(SUCH AS OTHER ORAL
CONTRACEPTIVES).
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on th

Summary of Product characteristics

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AUSTRALIAN PRODUCT INFORMATION -
TRIFEME
 (LEVONORGESTREL AND
ETHINYLESTRADIOL) TABLETS
1. NAME OF THE MEDICINE
Levonorgestrel and Ethinylestradiol
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each brown tablet contains 30 microgram of ethinylestradiol and 50
microgram of levonorgestrel.
Each white tablet contains 40 microgram of ethinylestradiol and 75
microgram of levonorgestrel.
Each
yellow
tablet
contains
30
microgram
of
ethinylestradiol
and
125
microgram
of
levonorgestrel
Each red tablet contains no active ingredients.
EXCIPIENTS WITH KNOWN EFFECT

Sucrose

Lactose monohydrate
For the full list of excipients, see Section 6.1 - List of Excipients.
3. PHARMACEUTICAL FORM
Tablet, sugar coated.
Each blister contains 6 brown tablets, followed by 5 white tablets,
followed by 10 yellow tablets
and followed by 7 red inert tablets.
Brown tablets: Round, biconvex, sugar coated brown tablets with
diameter of approximately 6
mm.
White tablets: Round, biconvex, sugar coated white tablets with
diameter of approximately 6
mm.
Yellow tablets: Round, biconvex, sugar coated yellow tablets with
diameter of approximately 6
mm.
Red tablets: Round, biconvex, sugar coated red inert tablets.
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4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TRIFEME is indicated for the prevention of pregnancy.
4.2 DOSE AND METHOD OF ADMINISTRATION
_HOW TO TAKE TRIFEME _
Each package of TRIFEME contains 6 brown active tablets, 5 white
active tablets, 10 yellow
active tablets and 7 red inactive tablets. To achieve maximum
contraceptive effectiveness,
TRIFEME must be taken as directed and at intervals not exceeding 24
hours. Women should be
instructed to take the tablets at the same time every day, preferably
after the evening meal or at
bedtime.
_HOW TO START TRIFEME _
NO PRECEDING HORMONAL CONTRACEPTIVE USE (IN THE PAST MONTH)
On the first day of the menstrual cycle, i.e. the first day of
bleeding, the woman will take